Arrangement of factory Inspection to get Ukrainian GMP approval or get a Conclusion on the recognition of PIC/S Certificates
Any medicinal product, which subject to registration in Ukraine and sales after registration in Ukrainian market, require the approval for GMP to the manufacturing Plant by the State Service of Ukraine on medicine and drug control under MOH, Ukraine.
The State Service of Ukraine on medicine and drug control issues the following documents certifying that the conditions of manufacture of medicinal products meet the requirements of GMP:
- Certificate of compliance of the conditions of production of medicines with the requirements of good manufacturing practice;
- Conclusion on confirmation of compliance of the conditions of production of medicinal products with the requirements of good manufacturing practice (based on certificate of conformity of conditions of production of medicinal products with the requirements of GMP, issued by the authorized body of the member country of PIC / S)
Stages of confirmation of compliance of conditions of manufacture of medicines with requirements of GMP:
- Submission an application to The State Service of Ukraine on medicine and drug control for the Certificate or the application for Issuance of the Opinion/Conclusion require the set of documents stipulated by the existing regulatory
- Verification and processing to The State Service of Ukraine on medicine and drug control filling an Application for the Certificate GMP or the Application for Issuance of the Opinion/Conclusion require initial examination and specialized examination;
- To obtain the Certificate GMP – conducting inspection of production plant of medicinal products at the place of activity, including laboratories performing quality control under contract (contract), warehouse areas under contract (contract), in the cases provided by existing regulatory.
To organization to obtain a GMP compliance certificate.